Methods And Systems For Treatment Of Acute Ischemic Stroke

Patent No. US12262911 (titled "Methods And Systems For Treatment Of Acute Ischemic Stroke") was filed by Route 92 Medical Inc on Sep 3, 2020.

What is this patent about?

’911 is related to the field of medical devices, specifically those used for treating acute ischemic stroke. The background of the invention lies in the challenges associated with accessing and treating cerebral occlusions, where quick intervention is crucial. Existing methods, often involving transfemoral access, can be time-consuming and carry a risk of embolic complications due to the tortuous path through the aortic arch and carotid arteries. The invention aims to provide a faster and safer route to the cerebral vasculature.

The underlying idea behind ’911 is to simplify and expedite access to cerebral arteries by using a transcervical approach directly to the common carotid artery. This shorter, straighter path reduces the risk of embolic events and decreases the time required to reach the occlusion. The key insight is that direct access to the carotid artery, combined with specialized catheters and aspiration techniques, can significantly improve stroke treatment outcomes.

The claims of ’911 focus on a catheter system designed for navigating the cerebral vasculature. The system includes a catheter and an inner member (dilator) with a tapered distal portion. This tapered design creates a smooth transition in flexibility between the guidewire and the catheter, facilitating advancement through tortuous vessels, specifically beyond the petrous portion of the internal carotid artery. The claims emphasize the assembled system's flexibility and ability to reach distal locations in the cerebral vasculature.

In practice, the system works by first inserting a guidewire into the cerebral vessel. The catheter and inner member assembly are then advanced over the guidewire. The tapered inner member minimizes any 'step' or abrupt change in diameter at the catheter tip, allowing for smoother navigation through tight turns and past vessel bifurcations. Once the catheter is in position, the inner member can be removed, leaving the catheter in place for subsequent procedures like aspiration or thrombectomy.

This approach differentiates itself from prior methods by offering a more direct and less invasive route to the cerebral arteries. The shorter path and smoother transition at the catheter tip reduce the risk of vessel damage and embolic complications. By combining direct access with a carefully designed catheter system, ’911 aims to improve the speed and safety of stroke interventions, ultimately leading to better patient outcomes. The tapered dilator is a key element in achieving this improved navigation.

How does this patent fit in bigger picture?

Technical landscape at the time

In the early 2010s when ’911 was filed, neurointerventional procedures commonly relied on transfemoral access to the cerebral arteries, at a time when device access challenges made B non-trivial. At a time when X was typically implemented using Y, embolic protection systems were not commonly used in interventional treatment of acute ischemic stroke due to the delicate anatomy and the need for rapid intervention.

Novelty and Inventive Step

The examiner approved the claims because the prior art, including Garrison, Chou, and Wilson, failed to disclose or suggest the unique combination of structure and function recited in the claims. Specifically, the examiner noted that the prior art did not teach a catheter system where, with the inner member in the advancement configuration and the guidewire extending distally, the inner member creates a smooth transition in flexibility between the guidewire and the catheter's distal end. This configuration allows the catheter and inner member to be advanced together over the guidewire to a petrous portion of an internal carotid artery. The examiner stated that this arrangement addresses the diameter mismatch in existing systems, which causes difficulty when navigating tortuous vessels.

Claims

This patent contains 25 claims, with claims 1 and 18 being independent. The independent claims are directed to a system of devices for performing a medical procedure in a cerebral vessel, comprising a catheter, an inner member, and a guidewire. The dependent claims generally elaborate on specific features, dimensions, materials, and configurations of the system components described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Advancement configuration
(Claim 1, Claim 18)
“Described herein are methods and devices that enable safe, rapid and relatively short and straight transcervical access to the carotid arteries and cerebral vasculature for the introduction of interventional devices for treating ischemic stroke.”A relative positioning of the inner member and catheter where the inner member extends through the catheter lumen, with the distal portion positioned distal to the distal end of the catheter.
Catheter lumen
(Claim 1, Claim 18)
“Described herein are methods and devices that enable safe, rapid and relatively short and straight transcervical access to the carotid arteries and cerebral vasculature for the introduction of interventional devices for treating ischemic stroke.”The hollow space within the catheter through which the inner member slides. It has an inner diameter and a distal end.
Inner member
(Claim 1, Claim 18)
“Described herein are methods and devices that enable safe, rapid and relatively short and straight transcervical access to the carotid arteries and cerebral vasculature for the introduction of interventional devices for treating ischemic stroke.”A component sized and shaped to slide within the catheter lumen. It has a single lumen, a distal portion, and a distal-most end.
Petrous portion
(Claim 1, Claim 18)
“Transcervical access provides a short length and non-tortuous pathway from the vascular access point to the target cerebral vascular treatment site, thereby easing the time and difficulty of the procedure, compared for example to a transfemoral approach.”A specific anatomical region of the internal carotid artery, distal to which the assembled catheter system is configured to be advanced.
Smooth transition in flexibility
(Claim 1, Claim 18)
“Described herein are methods and devices that enable safe, rapid and relatively short and straight transcervical access to the carotid arteries and cerebral vasculature for the introduction of interventional devices for treating ischemic stroke.”A gradual change in flexibility created by the distal portion of the inner member between the guidewire and the distal end of the catheter.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-00986Aug 6, 2025Route 92 Medical, Inc. V. Balt Usa, Llc

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US12262911

ROUTE 92 MEDICAL INC
Application Number
US17011448
Filing Date
Sep 3, 2020
Status
Granted
Expiry Date
Nov 9, 2035
External Links
Slate, USPTO, Google Patents